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U.S. Department of Health and Human Services

Class 3 Device Recall AngioSeal

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 Class 3 Recall
AngioSeal
see related information
Date Posted November 07, 2006
Recall Status1 Terminated on November 13, 2006
Recall Number Z-0157-2007
Recall Event ID 35819
Premarket Approval
PMA Number
P930038/S040
Product Classification Device, Hemostasis, Vascular - Product Code MGB
Product The affected device is labeled Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size.
Code Information Lot 1204437
Recalling Firm/
Manufacturer
St. Jude Medical / Daig Division
14901 Deveau Pl
Minnetonka, Minnesota 55345-2126
Manufacturer Reason
for Recall
The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action All consignees were notified by letter on June 7, 2006. All product is to be retreived by recalling firm''s sales force for return to St. Jude Medical, in Minnetonka, MN.
Quantity in Commerce 4,770 Units
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MGB and Applicant = ST. JUDE MEDICAL, INC.
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